China’s NMPA Approves Kelun-Biotech's Sacituzumab Tirumotecan (sac-TMT) for EGFR-mutant NSCLC
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- China’s NMPA has approved label expansion of sacituzumab tirumotecan (SKB264/MK-2870) to locally advanced or metastatic (LA/M) EGFRm NSCLC following disease progression on EGFR-TKI therapy or Pt-based Ct
- Approval was based on OptiTROP-Lung03 trial assessing sac-TMT alone (5mg/kg, IV, Q2W) vs docetaxel in mentioned pts, where it demonstrated improved ORR, PFS & OS
- sac-TMT is fully deployed in NSCLC, with Merck & Kelun conducting 10 global & China-based P-III trials from late-line to early postoperative adj. settings, incl. a P-III (OptiTROP-Lung07) trial evaluating it in combination with osimertinib for 1L LA/M EGFRm NSCLC in China
Ref: Kelun-Biotech | Image: Kelun-Biotech
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Ridhi is an avid secondary researcher who follows trends in the biopharmaceutical and healthcare sectors to curate engaging content for the global audience. She works as a news editor at PharmaShots and loves to read books and explore new destinations.
